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Puma (PBYI) Q4 Loss Wider than Expected, Neratinib in Focus
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Puma Biotechnology, Inc. (PBYI - Free Report) reported a fourth-quarter 2016 loss of $2.04 per share (including the impact of stock-based compensation expenses), wider than both the Zacks Consensus Estimate of a loss of $2.02 and the year-ago loss of $1.90.
So far this year, Puma’s shares significantly outperformed Zacks classified Medical-Biomedical and Genetics industry. Specifically, the company’s shares gained 24.1%, while the industry registered an increase of 8.7%.
With no approved products in Puma Biotech’s portfolio at the moment, the company does not generate revenues yet.
In the fourth quarter, research and development (R&D) expenses were $56.4 million, up 7.4% from the year-ago quarter. General and administrative expenses increased 71.9% year over year to $16.5 million.
Focus on Neratinib
Puma Biotech has made significant progress with its lead candidate, neratinib. Currently, the drug is under review in both the U.S. and the EU for the treatment of HER2-positive breast cancer.
Several phase II studies evaluating neratinib for the treatment of breast cancer are currently underway. On Dec 2016, the company presented positive interim results from the phase II CONTROL study on neratinib at the SABCS. The international, open-label, phase II study evaluated the use of loperamide prophylaxis with or without other agents for the prevention and reduction of neratinib-associated diarrhea and more specifically, grade 3 diarrhea.
Moreover, during the same month Puma initiated a managed access program for neratinib. The company has partnered with Caligor Opco, which specializes in early access to medicines, to implement and oversee the managed access program for neratinib. Caligor will also provide regulatory, logistical and supply chain support.
The company anticipates several pipeline-related updates in 2017. It plans to report additional data from the phase II study on neratinib as an extended adjuvant treatment of HER2-positive early-stage breast cancer using loperamide and budesonide prophylaxis in the second quarter of 2017.
Further, the company expects to report interim Phase I/II data in the second quarter of 2017 from the NSABP FB-10 trial of neratinib plus Kadcyla (T-DM1) in HER2-positive metastatic breast cancer (MBC). Moreover, the company expects to report phase II data in the same period from the SUMMIT basket trial of neratinib in HER2-negative breast cancer patients with HER2 mutations.
Given that Puma Biotech has no approved products in its portfolio at the moment and neratinib is its lead candidate, we expect investor focus to remain on updates pertaining to its development.
2016 Results
The full-year loss of $8.29 per share was wider than Zacks Consensus Estimate of a loss of $8.05. The company had incurred loss of $7.45 per share a year ago.
Puma Biotechnology Inc Price, Consensus and EPS Surprise
Cellectis’ loss per share estimates narrowed from $2.33 to $1.80 for 2016 and from $2.94 to $1.69 for 2017 over the last 30 days. The company posted positive surprises in three of the four trailing quarters with an average beat of 111.20%.
Celgene’s earnings per share estimates increased from $6.52 to $6.60 for 2017 and from $8.15 to $8.16 for 2018 over the last 60 days. The company posted positive earnings surprises in three of the four trailing quarters with an average beat of 5.08%.
Sunesis’ loss per share estimates narrowed from $2.57 to $2.44 for 2016 and from $2.16 to $1.97 for 2017 over the last 60 days. The company posted positive earnings surprises in three of the four trailing quarters with an average beat of 0.54%.
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Puma (PBYI) Q4 Loss Wider than Expected, Neratinib in Focus
Puma Biotechnology, Inc. (PBYI - Free Report) reported a fourth-quarter 2016 loss of $2.04 per share (including the impact of stock-based compensation expenses), wider than both the Zacks Consensus Estimate of a loss of $2.02 and the year-ago loss of $1.90.
So far this year, Puma’s shares significantly outperformed Zacks classified Medical-Biomedical and Genetics industry. Specifically, the company’s shares gained 24.1%, while the industry registered an increase of 8.7%.
With no approved products in Puma Biotech’s portfolio at the moment, the company does not generate revenues yet.
In the fourth quarter, research and development (R&D) expenses were $56.4 million, up 7.4% from the year-ago quarter. General and administrative expenses increased 71.9% year over year to $16.5 million.
Focus on Neratinib
Puma Biotech has made significant progress with its lead candidate, neratinib. Currently, the drug is under review in both the U.S. and the EU for the treatment of HER2-positive breast cancer.
Several phase II studies evaluating neratinib for the treatment of breast cancer are currently underway. On Dec 2016, the company presented positive interim results from the phase II CONTROL study on neratinib at the SABCS. The international, open-label, phase II study evaluated the use of loperamide prophylaxis with or without other agents for the prevention and reduction of neratinib-associated diarrhea and more specifically, grade 3 diarrhea.
Moreover, during the same month Puma initiated a managed access program for neratinib. The company has partnered with Caligor Opco, which specializes in early access to medicines, to implement and oversee the managed access program for neratinib. Caligor will also provide regulatory, logistical and supply chain support.
The company anticipates several pipeline-related updates in 2017. It plans to report additional data from the phase II study on neratinib as an extended adjuvant treatment of HER2-positive early-stage breast cancer using loperamide and budesonide prophylaxis in the second quarter of 2017.
Further, the company expects to report interim Phase I/II data in the second quarter of 2017 from the NSABP FB-10 trial of neratinib plus Kadcyla (T-DM1) in HER2-positive metastatic breast cancer (MBC). Moreover, the company expects to report phase II data in the same period from the SUMMIT basket trial of neratinib in HER2-negative breast cancer patients with HER2 mutations.
Given that Puma Biotech has no approved products in its portfolio at the moment and neratinib is its lead candidate, we expect investor focus to remain on updates pertaining to its development.
2016 Results
The full-year loss of $8.29 per share was wider than Zacks Consensus Estimate of a loss of $8.05. The company had incurred loss of $7.45 per share a year ago.
Puma Biotechnology Inc Price, Consensus and EPS Surprise
Puma Biotechnology Inc Price, Consensus and EPS Surprise | Puma Biotechnology Inc Quote
Zacks Rank & Key Picks
Puma currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Cellectis S.A. (CLLS - Free Report) , Celgene Corp. and Sunesis Pharmaceuticals, Inc. . Each of these stock carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Cellectis’ loss per share estimates narrowed from $2.33 to $1.80 for 2016 and from $2.94 to $1.69 for 2017 over the last 30 days. The company posted positive surprises in three of the four trailing quarters with an average beat of 111.20%.
Celgene’s earnings per share estimates increased from $6.52 to $6.60 for 2017 and from $8.15 to $8.16 for 2018 over the last 60 days. The company posted positive earnings surprises in three of the four trailing quarters with an average beat of 5.08%.
Sunesis’ loss per share estimates narrowed from $2.57 to $2.44 for 2016 and from $2.16 to $1.97 for 2017 over the last 60 days. The company posted positive earnings surprises in three of the four trailing quarters with an average beat of 0.54%.
The Best Place to Start Your Stock Search
Today, you are invited to download the full list of 220 Zacks Rank #1 "Strong Buy" stocks – absolutely free of charge. Since 1988, Zacks Rank #1 stocks have nearly tripled the market, with average gains of +26% per year. Plus, you can access the list of portfolio-killing Zacks Rank #5 "Strong Sells" and other private research. See these stocks free >>